Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 89
- Primary Endpoint
- Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4
Overview
Brief Summary
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •African American/ethnic black
- •Adults at least 18 years of age
- •Eyelash prominence assessment of minimal or moderate
Exclusion Criteria
- •Subjects with uneven lashes or longer on one side than the other
- •Any eye disease or abnormality
- •Eye surgery
- •Severe hyperpigmentation around the eye
- •Eyelash implants
- •Eyelash extension application
- •Any use of eyelash growth products within 6 months
- •Any use of prescription eyelash growth products
- •Treatments that may affect hair growth
- •Requiring eye drop medications for glaucoma
Arms & Interventions
LATISSE®
bimatoprost ophthalmic 0.03% solution
Intervention: bimatoprost ophthalmic 0.03% solution (Drug)
Placebo
vehicle sterile solution
Intervention: vehicle sterile solution (placebo) (Drug)
Outcomes
Primary Outcomes
Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4
Time Frame: Month 4
Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).
Secondary Outcomes
No secondary outcomes reported